Method of using integral aortic arch infusion clamp

ABSTRACT

An improved method of using a single catheter to infuse blood to the heart, clamping the aorta and delivering a cardioplegia solution. Patient trauma is significantly reduced using a single cannulation. A single catheter (10, 90, 92) is used having a unique balloon (56, 93, 102) for occluding the aorta. In a first embodiment, a single catheter (10) is positioned upwardly in the aorta to infuse oxygenated blood into the ascending aorta via an infusion lumen (72) terminating at the distal end (54), with cardioplegia solution being delivered via openings (82) defined closely adjacent the balloon (56) on the proximal side of the balloon. The inflated balloon (56) isolates the two delivery openings (72,82) from one another to facilitate use of an extracorporeal circuit. In a second embodiment, a single catheter (90) can be positioned downwardly in the aorta to infuse blood via openings (82) into the ascending aorta proximate the subclavian artery, and deliver cardioplegia solution via the distal opening (72) downward toward the aortic base. The balloon (102) is preferably filled with a partitioned resilient material (104) to permit varying diameters of the balloon and occlude body passageways having varying diameters and curvatures.

CROSS REFERENCE TO RELATED APPLICATIONS

Cross reference is made to the commonly assigned patent applicationAttorney's Docket Chase 03 entitled INTEGRAL AORTIC ARCH INFUSION CLAMPCATHETER filed herewith.

FIELD OF THE INVENTION

The present invention is generally related to cardiac cathetersincluding venous perfusion and arterial perfusion cardiac catheters forproviding cardiopulmonary bypass support and isolation of the heartwhile performing open heart surgery, and more particularly to animproved method for providing infusion of oxygenated blood, aorticclamping, and delivery of a cardioplegia solution.

BACKGROUND OF THE INVENTION

Use of catheters to administer fluids to and draw out of the body hasbeen a standard practice in medical procedures for years. Multiplecatheters are typically used to connect an extracorporeal circuit to thebody during open heart procedures. The various catheters aresimultaneously used to provide different functions, one catheter fordelivering a cardioplegia solution, with another catheter being insertedinto the heart to infuse oxygenated blood to the ascending aorta.

In a typical open heart procedure, blood is bypassed from the heart andlungs to a heart lung machine. When bypassing the heart, the blood issiphoned away from the superior vena cava and inferior vena cava,oxygenated, and then returned to the ascending aorta. The primary reasonfor using the extracorporeal circuit is to provide an empty andbloodless heart for the surgeon to effectively perform repair. In spiteof bypassing the blood from the heart, the heart muscle will still beat,primarily for two reasons. First, the heart muscle is still receivingoxygenated blood from the extracorporeal circuit. Secondly, the heart'selectrochemical activity is still functioning normally.

In a typical open heart procedure, the aorta is cannulated in twolocations. In a first location, the aorta is cannulated with a firstcatheter for returning oxygenated blood to the body from theextracorporeal circuit. Oxygenated blood is delivered to the heart witha catheter through the coronary arteries from the base of the aorta,known as the aortic base. To stop the flow of oxygenated blood to theheart, the ascending aorta is typically clamped distal to the coronaryostia, known as the opening for coronary arteries with a large stainlesssteel aortic cross clamp. Clamping the ascending aorta isolates thecoronary arteries from the extracorporeal circuit.

The aorta is cannulated in a second location using a second catheter todeliver cardioplegia. The electrochemical action of the heart can bestopped by infusing the heart muscle with a cardioplegia solution.Cardioplegia solution is typically rich in potassium ions. The potassiumions interrupt the heart's electrical signals, resulting in a stillheart. Stopping the heart gives a stable platform to effectively conductthe necessary repairs to the heart. The cardioplegia solution isdelivered to the heart muscle through the coronary arteries. This istypically accomplished by infusing the cardioplegia solution into theascending aorta with the second catheter between the large cross clampand the aortic valve located at the base of the aorta. The cross clampkeeps the cardioplegia and the oxygenated blood separated from oneanother.

There are three areas of concern in performing surgery in thisconventional, multi-cannulation approach. First, clamping the aortaexerts tremendous force on the aortic walls, and there is a potentialfor the arteriosclerotic plaque deposits on the aortic walls todislodge. Due to the proximity of the cross clamp to the carotid artery,this poses a special threat since the dislodged plaque can potentiallygo straight to the brain, resulting in a stroke to the patient.Secondly, the clamping pressure also causes damage to the delicateendothelial lining of the aorta, which is the inner surface of theartery. Post operative scaring of the endothelial lining can provide anirregular surface causing increased arteriosclerotic plaque build up.Finally, the two cannula suture sites created by the cardioplegiacannula and arterial return cannula tend to scar the aorta and make itvery difficult to find suitable cannulation sites for open heartprocedures in the future, if necessary.

One prior art method of addressing the short comings of currentmulti-cannulation procedures is by percutaneously accessing venous andarterial blood femorally, such as disclosed in U.S. Pat. No. 5,478,309to Sweeter, et al. This method, however, is cumbersome and is dependenton the skill level of the surgeon. Moreover, this percutaneous approachis a major deviation from the conventional methods.

Alternatively, cardioplegia can be delivered through the coronary sinusin conventional ways. Although this alternative approach helps avoid oneincision in the aorta, another incision is required in the right atrium,and the aortic clamp is still needed.

There is a desire to provide an improved method for infusing the heartwith oxygenated blood and delivering cardioplegia solution in a moreatraumatic way.

There is also a desire to provide an improved method for occluding abody vessel, such as the aorta, that has a varying diameter andcurvature.

SUMMARY OF THE INVENTION

The method of the present invention achieves technical advantages byusing only one unique catheter to accomplish all three functions of 1)infusing blood, 2) delivering cardioplegia solution, and 3) occludingthe aorta. The method uses a unique catheter inserted into the ascendingaorta that has a uniquely designed balloon at the distal end thereofwhich inflates to occlude the aorta and act as a clamp. An infusionopening is provided at the distal end of the catheter and infusesoxygenated blood into the ascending aorta above the balloon. Thecardioplegia solution is delivered through a separate opening adjacentand proximal to the balloon to deliver cardioplegia to the coronaryarteries at the aortic base. The catheter is a multi-lumen tube whereinthe largest lumen is used for delivering the oxygenated blood to theascending aorta. A first lumen is used for infusing the oxygenatedblood, a second lumen is used to inflate or deflate the balloon, and thethird lumen is used to infuse the cardioplegia solution.

According to the first preferred method of the present invention, theneed for a cross clamp is eliminated as the novel expandable balloon isused to occlude the aorta. The balloon preferably is filled with aresilient material, such as foam or a gel to provide a gentle atraumaticforce that expands inside the aorta, and significantly reduces potentialdamage to the endothelial layer of the aorta. Additionally, theelimination of the cross clamp reduces the potential for anyarteriosclerotic plaque to dislodge from the aorta. Only one moderatesize incision is required into the ascending aorta for insertion of thecatheter, which reduces the necessary trauma to the heart.

According to the preferred method of the present invention, the integralinfusion catheter is inserted into the ascending aorta such that thecatheter distal end extends upwardly into the ascending aorta to infuseoxygenated blood out the distal end of the catheter proximate theexpanded balloon. The cardioplegia solution is delivered via an openingclosely proximate and at the other side of the balloon, the openingbeing defined on the proximal side of the balloon. The cardioplegiaopening may also be used to intermittently administer oxygenated bloodto the heart muscle and coronary artery. Preferably, the balloon ispositioned in the ascending aorta such that the balloon resides abovethe aortic base with oxygenated blood being infused into the aorticarch. More specifically, the balloon is positioned between the aorticbase and the subclavian artery.

In an alternative method of the present invention, the catheter can beinserted into the ascending aorta in the reverse orientation. That is,the distal end of the catheter can be directed downwardly toward theaortic base, with the cardioplegia solution being dispensed out thedistal end of the catheter. The opening on the other side of theballoon, which is defined between the balloon and the catheter proximalend, is used to infuse oxygenated blood into the ascending aorta.

In yet a further alternative embodiment, the balloon is uniquelydesigned to be filled with, or encompassed by, a resilient material suchas a foam or gel to provide a nominal diameter when no pressure isapplied. The resilient material is preferably partitioned into sectionsto facilitate further expansion of the balloon in a body vessel having avarying diameter or curvature.

In still yet a further embodiment of the invention the balloon may have2 lobes defining a cavity therebetween when inflated in the aorta tocreate a bloodless region. This bloodless region facilitates performingan anastomosis in a clear field when attaching a saphenous vein to theaorta.

Irregardless of which method is utilized, a single multi-lumen catheteris utilized which requires only one incision in the ascending aorta. Thecatheter provides the three necessary functions of occluding the aorta,infusing oxygenated blood, and delivering the cardioplegia solution. Themethod of using the catheter having the uniquely designed balloon isadapted for occluding any body vessel having a varying diameter andcurvature, such as the trachea.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is an illustration of a single multi-lumen catheter properlyinserted into the ascending aorta according to the preferred method ofthe present invention;

FIG. 2 is a sectional side view of the integral catheter utilized toconduct the method in FIG. 1, the catheter shown as having three lumens,the first for inflating the balloon, the second for infusing oxygenatedblood out the distal end of the catheter proximate the balloon, and thethird lumen for dispensing a cardioplegia solution closely proximate theballoon and proximal of the balloon;

FIG. 3 is a cross section of the catheter taken along lines 3--3 in FIG.2 illustrating the location and relative diameters of the three lumens;

FIG. 4 is an illustration of an alternative preferred method of thepresent invention whereby the single multi-lumen catheter is insertedinto the ascending aorta with the catheter distal end oriented towardthe aortic base for delivery of the cardioplegia solution to the aorticbase, with the oxygenated blood being infused via catheter openingsclosely proximate the balloon and proximal of the balloon, as shown;

FIG. 5 is a sectional side view of an integral catheter utilized toconduct the method in FIG. 4, wherein the larger lumen terminatesproximal of the balloon to infuse blood proximal of the downwardlyextending catheter;

FIG. 6 is a cross section of the catheter taken along lines 6--6 in FIG.5 illustrating the location and relative diameters of the three lumens;

FIG. 7 is a cross section of a catheter according to an alternativepreferred embodiment having a double lobe balloon for creating abloodless region in the aorta to perform an anastomosis of an artery;

FIG. 8 is a sectional sideview of a catheter according to an alternativepreferred embodiment of the present invention suitable for occluding anybody passageway, such as the aorta, seen to comprise an inner shell witha resilient material disposed thereabout and preferably encapsulated byan outer shell, the balloon having a nominal diameter when no pressureis applied, and an increased diameter when a pressure is applied tofurther expand the balloon;

FIG. 9 is a cross section of the balloon in FIG. 8 taken along line 9--9to illustrate the resilient foam material encapsulated between the innerballoon shell and the outer balloon shell;

FIG. 10 is an illustration of the catheter of FIG. 8 in the expandedstate with a pressure applied to the inner balloon shell, compressingthe resilient foam material to further expand the overall diameter ofthe balloon;

FIG. 11 is a sectional view of an alternative preferred embodiment ofthe catheter shown in FIG. 8 whereby the resilient foam material ispartitioned into sections, each section being separated by radiallyextending opposing edges about the catheter body;

FIG. 12 is a sectional view also taken along line 9--9 in FIG. 8illustrating the embodiment of FIG. 11 in the expanded state, with theresilient foam sections expanding radially outward and away from oneanother to further increase the diameter of the catheter when pressureis applied to the balloon via the associated lumen;

FIG. 13 is yet another alternative preferred embodiment of the presentinvention from that of FIG. 8 and FIG. 11, when the resilient foammaterial is partitioned in the transverse direction with respect to thecatheter body;

FIG. 14 is a sectional side view taken along line 14--14 in FIG. 13illustrating the annular resilient foam sections;

FIG. 15 is a sectional side view of the catheter of FIG. 13 illustratingthe balloon in the expanded state, whereby the annular resilient foamsections expand outwardly and away from one another as pressure isapplied via the associated balloon lumen to expand the outer balloonshell and increase the overall diameter of the balloon as a function ofthe pressure applied; and

FIG. 16 is a sectional side view of a catheter having a fourth lumen forsensing pressure and/or venting the left ventricle of the heart whenused in the orientation shown in FIG. 4.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT OF THE PRESENTINVENTION

First with reference to FIG. 1, there is shown the first preferredmethod of the present invention. As shown in FIG. 1, a singlemulti-lumen catheter 10 is utilized for cannulating the ascending aorta12 of a human heart 14. For reference purposes, the right atrium isshown at 16, with the inferior vena cava being shown at 18 and superiorvena cava being shown at 20. The subclavian artery is shown at 22.

Catheter 10 is upwardly positioned within the ascending aorta 12, asshown, by first creating a suitable incision in the aorta proximate theaortic base, shown at 30. The distal end 32 of catheter 10 is insertedinto the incision of the aorta just over the aortic base, with thedistal end 32 being advanced upwardly into the ascending aorta 12 untila reference marker 34 of catheter 10 is located adjacent incision 30. Asshown in FIG. 1, the distal end 72 is oriented upwardly proximate thesubclavian artery 22. An inflatable balloon 56 of catheter 10 iscarefully positioned between the aortic base but ahead of the leftsubclavian artery 22. In this orientation, a plurality of cardioplegiadelivery openings 82 are oriented above and proximate the aortic base 42of the heart.

When the surgeon is prepared to put the patient on the extracorporealcircuit, the balloon 56 is inflated with air or a saline solution untilthe balloon's force can be felt by the surgeon's hand outside the aorticwalls. This pressure assures that the aorta is fully occluded. Justprior to inflating the balloon, the main lumen of the catheter isconnected to an oxygenated blood source and infuses oxygenated blood outof the distal end of the catheter into the ascending aorta 12. When theballoon is fully inflated, the patient is properly connected to theextracorporeal circuit.

Next, a predetermined quantity of cardioplegia solution is delivered viathe cardioplegia openings 82. This cardioplegia solution is provided tothe aorta between the aortic valve and the balloon clamp. Theelectrochemical action of the heart is stopped by infusing the heartmuscle with the cardioplegia solution. This cardioplegia solution istypically rich in potassium ions, which potassium ions interrupt theheart electrical signals resulting in a still heart. Stopping the heartgives a stable platform to effectively conduct the necessary proceduresto the heart.

It is particularly noted according to the present invention that onlyone moderate incision 30 is required to cannulate the ascending aorta 12to achieve all three functions. This significantly reduces the trauma tothe aorta as compared to other conventional and alternative approaches.Since the inflatable balloon is utilized to occlude the ascending aorta,the need for a cross clamp is eliminated, and the possibility ofdislodging plaque is significantly reduced. In addition, the delicateendothelial lining of the aorta is gently engaged.

Referring now to FIG. 2, there is shown a side sectional view of anintegral catheter 10 which is suited for achieving the method of thepresent invention. Catheter 10 is seen to include an elongated catheterbody 50 extending between a proximal end 52 and a distal end 54.Provided at the distal end of catheter 10 is an inflatable balloon 56which is secured circumferentially about the catheter by an adhesive orother suitable affixing means. The balloon 56 may be filled with a foamor other resilient material, or simply left empty. A first smaller lumen60 extends longitudinally through catheter 10 and is in fluidcommunication within the interior 62 of balloon 56 via an opening 64defined through body 50. A larger, second lumen 70 extendslongitudinally from the catheter proximal end through catheter 10 andopens at a distal opening 72 at distal end 54. A smaller third lumen 80extends from the proximal end of catheter 10 and terminates via aplurality of openings 82 defined through body 50. The openings 82 arenecessarily provided closely adjacent to the expandable balloon 56, buton the proximal side of the balloon, opposite the infusion distalopening 72. Thus, openings 72 and 82 are provided on opposite sides ofballoon 56. In use, the inflated balloon 56 sealingly isolates openings72 and 82 from one another for infusing blood out one side, anddelivering cardioplegia solution out the other.

Catheter body 50 is preferably comprised of suitable flexible plasticmaterial, such as silicone, PVC or other thermoplastics according towell known techniques. Preferably, the diameter of the main infusionlumen 70 is 0.250 inches. The diameter of the smaller inflating lumen 60is about 0.030 inches, and the cardioplegia lumen 82 has a diameter ofabout 0.100 inches.

Referring to FIG. 3, the relative diameters and locations of the threelumens are shown, again, with the main infusion lumen 70 having thelargest diameter for delivering oxygenated blood to the ascending aorta.

Sometimes the surgeon may find it necessary to perfuse oxygenated bloodto the heart muscle and the coronary artery instead of deliveringcardioplegia. This can be accomplished using catheter 10 according tothe present invention by selectively administering oxygenated blood tothe heart muscle and coronary artery through the cardioplegia lumen 80via openings 82. Cardioplegia and oxygenated blood can be alternatelyadministered above the aortic base to control the response of the heartmuscle to the cardioplegia during surgery, and assisting the heart inresuming a normal beat after surgery.

Turning now to FIG. 4, there is shown an alternative method of thepreferred invention whereby the orientation of a catheter 90 in theaorta is reversed. That is, the catheter 90 is inserted into incision 32of the ascending aorta 12, but at a location further upward than thatshown in FIG. 1, close to the subclavian artery 22 such that thecatheter 90 extends downwardly, as shown. The distal end 54 of thecatheter is advanced proximate the aortic base 42 and deliverscardioplegia solution therefrom. The openings 82 proximate balloon 56are positioned above the balloon 56, toward to subclavian artery 22 forinfusion of oxygenated blood into the ascending aorta 12.

Referring to FIG. 5, wherein like numerals refer to like elements, inthis embodiment the diameter of the lumen 80 infusing blood into theascending aorta is designed to have a much larger diameter than eitherthe lumen 70 delivering cardioplegia solution to the distal end of thecatheter or lumen 60 for inflating balloon 56. The diameter of the thirdlumen 80 of catheter 90 is increased to have a diameter of between 0.250and 0.350 inches for providing a suitable flow rate of oxygenated bloodvia openings 82 to the ascending aorta. The diameter of the second lumen70 delivering the cardioplegia solution out distal opening 72 is reducedto about 0.060 inches, which is suitable to deliver the necessaryquantity of cardioplegia to the heart. The diameter of the first lumen60 is still 0.040 inches for inflating balloon 56. FIG. 6 shows therelative orientation and diameters of the lumens of FIG. 5, taken alongline 6--6.

In both preferred methods of the present invention shown in FIGS. 1 and4, only one moderate incision of approximately 0.5 inches in length isrequired to be provided in the ascending aorta 12 for insertion ofcatheter 10 and catheter 90. This reduces the overall trauma to theaorta as compared to other alternative and conventional approaches.Moreover, use of balloon 56 to occlude the aorta reduces trauma to theaorta, and significantly reduces the chance that plaque will bedislodged which could result in a stroke to the patient. The endotheliallining of the aorta is maintained. The methods of the present inventioncan be performed relatively quick by the surgeon, which reduces cost andthe possibility of further complications as compared to multiplecannulation of the aorta.

The catheter body 50 is sufficiently flexible to allow maneuverabilitywithout kinking in the ascending aorta, allowing easy manipulation ofthe catheter within the aorta as shown in FIG. 1 and FIG. 4. If desired,the catheter could be designed to be extra resilient between theproximal end and opening 82 to further allow maneuverability of thecatheter without kinking at the cannulation site 34.

The longitudinal compactness of the operative features of both catheters10 and 90 facilitate the effective use of the single catheter. Theinflated balloon 56 typically has a diameter of about 1 inch, with theseveral openings 82 being provided immediately adjacent the balloon 56,and with the distal end and opening 72 being no more than 0.5 inchesfrom balloon 56, as shown. The overall distance between the proximalopenings 82 and the distal end 54 of catheter 50 is ideally no more thanabout 2 inches for a use in the typical human heart. Thus, thedimensions to these features of the catheters 10 and 90 is critical tofacilitate effective use of the present invention.

Typically during a bypass surgery the blocked artery is bypassed byattaching a saphenous vein graft to the artery distal to the occlusionwhile the other end of the graft is attached to the aorta. The surgeontypically performs an anastomosis to the artery first, followed by theanastamosis to the aorta. Since the aorta is filled with blood orcardioplegia, the surgeon may not have good visibility when an incisionis made in the aorta. This reduces his ability to perform theanastamosis. To avoid this problem and to enhance the visibility duringthe surgery, a catheter having a specially shaped balloon can be used. Acatheter 92 having a balloon 93 shown in FIG. 7 is suitable, and has twobulbs or lobes 94 creating two seals 95 with the adjacent wall 96 of theaorta 12. The area 97 in between these two bulbs 94 creates a bloodlessarea for the surgeon to perform the anastomosis in a clear field.

Referring to FIG. 7, wherein like numerals refer to like elements, thereis shown catheter 92 whereby the single balloon 93 is formed to have twolobes or bulbs 94 by securing an annular constriction, such as a ring 98about the midsection of the balloon 93, allowing the two lobes 94 toremain in fluid communication with each other for inflation by thesingle inflation lumen 60. The ring 98 is preferably secured to balloon93 with a suitable adhesive. Alternatively, the balloon 93 could simplybe formed to have two lobes without the need for a ring, but thisapproach is more intricate and expensive. Similarly, two separateballoons comprising a proximal balloon and a distal balloon could beprovided, both in fluid communication with lumen 60 if desired, theproximal balloon being no more than 3 inches from the catheter distalend. The saphenous vein to be attached to the aorta is shown at 99.

Referring now to FIG. 8, there is shown generally at 100 a catheter witha uniquely designed balloon generally shown at 102. Catheter 100 issimilar to catheter 10 shown in FIG. 2 and catheter 90 shown in FIG. 5,wherein like numerals refer to like elements. Balloon 102 is designed toallow even more control of the overall balloon diameter. The nominalstate of the balloon 102 is shown in FIG. 8, wherein a resilientmaterial 104, such as foam, determines the nominal diameter. When apressure is applied to lumen 60, the overall diameter of the balloon canbe increased approximately 20% beyond the nominal diameter, as shown inFIG. 10. The catheter 100 of the present invention is ideally suitablefor occluding an aorta, however, the present invention finds suitablepreferred use for occluding other body passageways, such as the trachea,and limitation to use in a vessel of the heart is not to be inferred bythe present invention. The present invention is discussed with referenceto occluding the aorta for illustration and clarity and forunderstanding the present invention.

Still referring to FIG. 8, catheter 100 is seen to have a catheter body50 extending to a distal end 54, similar to catheter 10 in FIG. 2.Balloon 102 has a first resilient inner shell 106 disposed about thecatheter body 50 and covering the opening 64 of lumen 60. The innershell 106 is secured and sealed to catheter body 50 at each end thereofusing a suitable adhesive, although heat could also be used to fuse theballoon shell 106 to the body of catheter 50. Disposed about the innershell 106 is an oval or generally egg-shaped unitary piece of theresilient material 104, such as foam. An outer resilient shell 110 isseen to encapsulate the foam material 104, the foam material 104residing between the inner shell 106 and the outer shell 110. The outershell 110 is comprised of a resilient material similar to that of innershell 106, and overlaps the sealed edges of inner shell 106. Outer shell110 is slipped over and sealed to both the distal ends of inner shell106 and also to the catheter body 50 using a suitable adhesive, althoughheat or other suitable attachment means is appropriate. A coating may beused in place of outer shell 110 if desired. The outer curvature ofresilient material 104 defines the shape and diameter of the balloon102.

Referring to FIG. 9, there is shown a cross section of the novel balloon102 taken along line 9--9 in FIG. 8. The resilient foam material 104 ispreferably comprised of an open-cell foam material, such aspolyurethane, but could also comprise of a closed-cell material such aspolyethylene if desired to eliminate the need for the outer shell 110.In this alternative embodiment, each end of the non-absorbing foammaterial 104 is sealed to the catheter body 50 to allow inner balloon106 to expand under the closed-cell material. The inner shell 106 andouter shell 110 preferably comprise of a soft material such as silicone.The resilient material 104 is preferably harder and less resilient thanthe inner shell 106 and the outer shell 110 to facilitate expansion ofthe outer shell 110. The resilient material 104 may also comprise of agel or other form changing material. The second perfusion lumen 70 isseen to extend the length of the catheter 100 and terminate at opening72. The third lumen 80 can be provided as well if desired, terminatingat proximate openings 82, as shown in FIG. 2.

Referring now to FIG. 10, there is shown catheter 100 with the balloon102 in the expanded state when positive pressure is applied to the innerballoon shell 106 via the balloon lumen 60. The inner balloon shell 106is seen to expand and define a cavity 116. As the inner shell 106expands, this compresses the resilient foam material 104 outwardly, asshown, further stretching the outer shell 110 to increase the overalldiameter of the balloon 102. Due to the resiliency of the resilientmaterial 104, the resilient material 104 will compress slightly wherebya 20% expansion of the inner shell 106 causes about a 10% expansion ofthe outer shell 110, and thus a 10% increase of the diameter of theballoon 102. The overall expansion of the balloon 102 is a function ofthe pressure applied to the balloon lumen 60. The expansion of balloon102 is generally linear with respect to the pressure applied to lumen60. The further expansion of the balloon 102 beyond its nominal diameteris especially useful for fully occluding a body passageway, such as anaorta, when the nominal diameter of the balloon is not quite sufficientto occlude the vessel, but wherein further expansion of the balloon doessuitably occlude the vessel to prevent fluid flow therethrough. Sincethe diameter of a body passageway, such as the aorta, can varysignificantly from one patient to another, the present invention findstechnical advantages by allowing the balloon 102 to customly fit to theinner diameter of a body passageway needing to be occluded, such as theaorta, a trachea, etc.

Referring now to FIG. 11, there is shown an alternative preferredballoon generally shown at 120. Balloon 120 is seen to be substantiallyidentical to balloon 102 in FIG. 8, wherein like numerals refer to likeelements. However, the resilient foam material 104 is seen to beradially partitioned into a plurality of segments 122 circumferentiallyabout the catheter body 50. In the nonexpanded state, as shown in FIG.10, the interfacing edges 124 of the sections 122 engage one another, asshown, with the overall diameter of the resilient material 104 being thesame as that shown in FIG. 8. The interfacing edges 124 of sections 122extend in the radial direction, as shown, with the width of each section22 being approximately equal.

Referring to FIG. 12, there is shown the modified balloon 120 in theexpanded state, whereby each of the resilient foam sections 122 are seento be separated from one another by corresponding gaps 128. Bypartitioning the resilient foam section 104 into modular sections 122,this further facilitates the expansion of the foam material 104 in theradial direction when a pressure is applied via lumen 60. For a givenpressure to lumen 60, the overall expansion of the foam material 104,and thus the outer shell 110, is increased from that of the embodimentin FIG. 8. For a given pressure, the balloon 102 of the embodiment ofFIG. 8 may increase 10%, but the overall diameter of balloon 120 in theembodiment of FIG. 11 will increase about 20%. Each of the resilientmaterial sections 122 are still encapsulated between the inner shell 106and the outer shell 110, as described with regards to balloon 102 inFIG. 8.

Referring now to FIG. 13, yet another alternative embodiment of acatheter is shown generally at 130 having a balloon 131. Catheter 130 isgenerally the same as catheter 100 in FIG. 8, wherein like numeralsrefer to like elements. However, in contrast to the resilient foamsections 104 shown in FIG. 8 or FIG. 11, the resilient foam material 104is partitioned into annular sections 132. Each of the annular sections132 abut against each other along section edges 134, each section 132being concentric with each other about the catheter body 50, as shown. Across section of the modified balloon 131 taken along line 14--14 isshown in FIG. 14.

Referring to FIG. 14, there is shown the modified balloon 131 in itsexpanded state, whereby the inner shell 106 is expanded by applying apressure via balloon 60. The inner shell 106 expands to define the innercavity 116. As the inner shell 106 expands, each of the annular sections132 expands outwardly, and separate from one another to define gaps 136.The expanding annular sections 132 expand radially outward to expand theouter shell 110, as shown, to further increase the overall diameter ofthe balloon 131. Similar to the partitioned foam material shown in FIG.11, by partitioning the resilient material 104 to provide a modularresilient sections, the resilient material 104 will compress and expandmore easily to increase the outer diameter of shell 110 for a givenpressure to lumen 60. In addition, by providing modular annular sections132, the curvature of the outer shell 110 will conform to the innercurvature of the body passageway that the balloon 131 is inserted into.For instance, if the inner wall of the aorta is curved, the outerdiameter of the balloon 131 will conform to this curvature to fullyocclude the passageway when inflated. Thus, the novel balloon 131 adaptsto the particular patient into which it is inserted. Likewise, themodular sections 122 in FIG. 11 also allow the diameter of the balloonto also conform to the body passageway to fully occlude the passagewayand prevent flow.

Referring to FIG. 16, wherein like numerals refer to like elements, acatheter 140 having a fourth lumen 142, is provided through the catheterbody 50 and terminate at the proximal end of the balloon, as shown, butcould also be provided distal of the balloon, if desired, to provide forpressure sensing or venting during use. The fourth lumen allows a bodypassageway pressure to be ascertained which is desirable to determine ifthe balloon is occluding the passageway as intended. If the pressuredetected via this fourth lumen 142 indicates that the balloon 56 is inits unexpanded state, or is not fully occluding the body passageway,pressure can be applied via lumen 60 to inflate the balloon, as shown inFIG. 10, FIG. 12 and FIG. 15 until the pressure reading indicates thepassageway is fully occluded. The fourth lumen also allows venting ofthe left ventricle of excess cardioplegia and blood to protect theendocardium when the apex of the heart is elevated. The fourth lumen 142also permits a malleable rod or material to be selectively insertedtherein to facilitate customly shaping the curvature of the catheterbody.

While the catheters having a unique balloon according to the embodimentsshown in FIG. 8-FIG. 16 are ideally suited for use for occluding theaorta, and are also ideally suited for use with the catheters 10 and 90for use as a multi-lumen catheter, the unique balloon catheters having aresilient material are well suited for performing other surgicalprocedures whereby clamping of a body passageway is desired. Accordingto one embodiment of the present invention, a single lumen catheterhaving a unique balloon with a resilient interior can be provided foroccluding a vessel, such as the trachea. Thus, the present invention issuitable for other percutaneous procedures besides aortic perfusion.

In summary, the alternative preferred embodiments shown in FIGS. 8-16are suitable for implementation in the multi-lumen aortic clampcatheters of FIG. 2 and FIG. 5, but also have more general purpose usesto occlude any body passageway, including passageways having uniquecurvatures and/or varying diameters. The partitioned resilient sectionsin the embodiments of FIG. 11 and FIG. 15 are well suited to conform tothe inner diameter of the passageway and fully occlude the passageway toprevent fluid flow therethrough. The additional expansion capabilitiesof the balloons including the resilient sections allows the catheter toconform to the particular passageway of many patients.

Though the invention has been described with respect to a specificpreferred embodiment, many variations and modifications will becomeapparent to those skilled in the art upon reading the presentapplication. It is therefore the intention that the appended claims beinterpreted as broadly as possible in view of the prior art to includeall such variations and modifications.

We claim:
 1. A method of providing cardiopulmonary bypass pump supportduring open heart surgery, wherein the heart has an ascending aorta, anaortic base, an aortic valve, an aortic arch, a coronary artery, and asubclavian artery, comprising the steps of:a) inserting an infusioncatheter having a proximal end and a distal end into the ascendingaorta, the catheter having a first lumen, a second lumen and a thirdlumen each extending between said proximal end and said distal end, saidcatheter having an expandable balloon proximate said distal end, saidfirst lumen in fluid communication with said balloon, said catheterhaving an infusion opening in fluid communication with said second lumenand located at said catheter distal end, said catheter having acardioplegia opening in fluid communication with said third lumendefined adjacent said balloon between said balloon and said catheterproximal end wherein said balloon comprises a flexible inner shelldisposed about said catheter, and a resilient material disposed aboutsaid inner shell adapted to conform to said ascending aorta, said firstlumen being in fluid communication with said flexible inner shell; b)advancing said infusion catheter upwardly into said ascending aorta suchthat said balloon is positioned above the aortic base and said catheterdistal end including said infusion opening is positioned toward saidaortic arch, said cardioplegia opening being positioned toward saidaortic base; c) infusing oxygenated blood into said aorta via saidcatheter second lumen through said infusion opening; d) expanding saidballoon to occlude said aorta with said resilient material compressingagainst and conforming to said aorta; and e) delivering a cardioplegiasolution to said heart via said catheter third lumen through saidcardioplegia opening to the heart.
 2. The method as specified in claim 1wherein said balloon is positioned in said step b) such that saidballoon is positioned between the aortic base and the subclavian artery.3. The method as specified in claim 1 wherein said oxygenated blood isdelivered in said step c) using an extracorporeal circuit.
 4. The methodas specified in claim 1 wherein said catheter is held in place withrespect to said aorta using purse string sutures.
 5. The method asspecified in claim 1 wherein said balloon is expanded in said step d) toocclude said aorta by inflating said balloon with a fluid until saidballoon can be felt from outside the aorta.
 6. The method as specifiedin claim 1 wherein said cardioplegia solution is delivered into theaorta between the aortic valve and said catheter balloon.
 7. The methodas specified in claim 1 wherein said catheter further comprises a fourthlumen extending from said proximal end to said distal end, furthercomprising the step of venting said heart via said fourth lumen.
 8. Themethod as specified in claim 1 wherein said balloon further comprises aflexible outer shell disposed about said resilient material.
 9. Themethod as specified in claim 8 wherein said resilient material comprisesfoam.
 10. The method as specified in claim 1 wherein said resilientmaterial is partitioned into sections, said sections interfacing oneanother along section edges.
 11. The method as specified in claim 10wherein said section edges extend longitudinally with respect to saidcatheter.
 12. The method as specified in claim 10 wherein said sectionedges extend transverse with respect to said catheter.
 13. The method asspecified in claim 1 wherein said resilient material comprises a closedcell foam.
 14. The method as specified in claim 1 further comprising thestep of delivering oxygenated blood to said coronary artery via saidcardioplegia opening.
 15. The method as specified in claim 1 whereinsaid balloon has a pair of lobes defining a cavity therebetween in saidaorta, further comprising the step of performing an anastomosis to saidaorta proximate said cavity.
 16. The method as specified in claim 15wherein said pair of lobes are defined by an annular constriction aboutsaid balloon.
 17. The method as specified in claim 1 wherein saidcatheter further comprises a fourth lumen extending from said proximalend to said distal end, further comprising the step of inserting amalleable material into said fourth lumen to permit shaping thecurvature of said catheter.
 18. A method of occluding a body passagewaywith a catheter having a catheter body extending between a proximal endand a distal end and having a lumen extending therethrough, saidcatheter having a balloon comprising a flexible inner shell disposedabout said catheter, a resilient material disposed about said innershell, and a continuous flexible outer shell sealingly disposed aboutsaid resilient material, comprising the steps of:a) inserting saidcatheter into said body passageway; and b) inflating said balloon toocclude said body passageway.
 19. The method as specified in claim 18wherein said first lumen is in fluid communication with said flexibleinner shell.
 20. The method as specified in claim 18 wherein saidresilient material comprises foam.
 21. The method as specified in claim19 wherein said resilient material is partitioned into sections, saidsections interfacing one another along section edges.
 22. The method asspecified in claim 21 wherein said section edges extend longitudinallywith respect to said catheter.
 23. The method as specified in claim 21wherein said section edges extend transverse with respect to saidcatheter.
 24. The method as specified in claim 19 wherein said resilientmaterial comprises a closed cell foam.